HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
0.1.0 - STU 1 Ballot

This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v0.1.0: STU 1 Ballot 1) based on FHIR R4. The current version which supercedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions

: VAERS Sample ICSR Report - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix loinc: <http://loinc.org/rdf#> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:Composition;
  fhir:nodeRole fhir:treeRoot;
  fhir:Resource.id [ fhir:value "VAERSExample"];
  fhir:Resource.meta [
     fhir:Meta.profile [
       fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-composition";
       fhir:index 0;
       fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-composition>     ]
  ];
  fhir:DomainResource.text [
     fhir:Narrative.status [ fhir:value "extensions" ];
     fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><blockquote><p><b>AdditionalDocumentInformation</b></p><p><b>value</b>: false</p></blockquote><blockquote><p><b>ExpeditedReport</b></p><p><b>value</b>: false</p><p><b>value</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.1003 2}\">Non-Expedited AE</span></p></blockquote><p><b>FirstSenderType</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.3 1}\">Regulator</span></p><p><b>CombinationProductReport</b>: false</p><p><b>FirstReceiveDate</b>: 2021-01-05</p><p><b>MostRecentDate</b>: 2021-01-05</p><p><b>CaseIdentifier</b>: id: US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495</p><p><b>identifier</b>: id: US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495</p><p><b>status</b>: final</p><p><b>type</b>: <span title=\"Codes: {http://loinc.org 85893-6}\">Adverse event note</span></p><p><b>category</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.2 1}\">Spontaneous report</span></p><p><b>date</b>: Jan 5, 2021 9:24:44 AM</p><p><b>author</b>: <a href=\"PractitionerRole-VAERSAuthorRole.html\">Generated Summary: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.6 1}\">Physician</span>; admin@admin.com, Phone: 3333333333</a></p><p><b>title</b>: ICSR Submission</p></div>"
  ];
  fhir:DomainResource.extension [
     fhir:index 0;
     fhir:Element.extension [
       fhir:index 0;
       fhir:Extension.url [ fhir:value "availableFlag" ];
       fhir:Extension.valueBoolean [ fhir:value "false"^^xsd:boolean ]     ];
     fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-additionaldocumentinformation" ]
  ], [
     fhir:index 1;
     fhir:Element.extension [
       fhir:index 0;
       fhir:Extension.url [ fhir:value "localCriteriaFlag" ];
       fhir:Extension.valueBoolean [ fhir:value "false"^^xsd:boolean ]     ], [
       fhir:index 1;
       fhir:Extension.url [ fhir:value "localCriteriaReportType" ];
       fhir:Extension.valueCodeableConcept [
         fhir:CodeableConcept.coding [
           fhir:index 0;
           fhir:Coding.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.1.1003" ];
           fhir:Coding.code [ fhir:value "2" ];
           fhir:Coding.display [ fhir:value "Non-Expedited AE" ]         ]       ]     ];
     fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-expeditedreport" ]
  ], [
     fhir:index 2;
     fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstsendertype" ];
     fhir:Extension.valueCodeableConcept [
       fhir:CodeableConcept.coding [
         fhir:index 0;
         fhir:Coding.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.1.3" ];
         fhir:Coding.code [ fhir:value "1" ];
         fhir:Coding.display [ fhir:value "Regulator" ]       ]     ]
  ], [
     fhir:index 3;
     fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-combinationproductreport" ];
     fhir:Extension.valueBoolean [ fhir:value "false"^^xsd:boolean ]
  ], [
     fhir:index 4;
     fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstreceivedate" ];
     fhir:Extension.valueDateTime [ fhir:value "2021-01-05"^^xsd:date ]
  ], [
     fhir:index 5;
     fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-mostrecentdate" ];
     fhir:Extension.valueDateTime [ fhir:value "2021-01-05"^^xsd:date ]
  ], [
     fhir:index 6;
     fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-caseidentifier" ];
     fhir:Extension.valueIdentifier [
       fhir:Identifier.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.3.2" ];
       fhir:Identifier.value [ fhir:value "US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495" ]     ]
  ];
  fhir:Composition.identifier [
     fhir:Identifier.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.3.1" ];
     fhir:Identifier.value [ fhir:value "US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495" ]
  ];
  fhir:Composition.status [ fhir:value "final"];
  fhir:Composition.type [
     fhir:CodeableConcept.coding [
       fhir:index 0;
       a loinc:85893-6;
       fhir:Coding.system [ fhir:value "http://loinc.org" ];
       fhir:Coding.code [ fhir:value "85893-6" ];
       fhir:Coding.display [ fhir:value "Adverse event note" ]     ]
  ];
  fhir:Composition.category [
     fhir:index 0;
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.1.2" ];
       fhir:Coding.code [ fhir:value "1" ];
       fhir:Coding.display [ fhir:value "Spontaneous report" ]     ]
  ];
  fhir:Composition.subject [
     fhir:Reference.reference [ fhir:value "Patient/VAERSPatient" ]
  ];
  fhir:Composition.date [ fhir:value "2021-01-05T14:24:44+05:00"^^xsd:dateTime];
  fhir:Composition.author [
     fhir:index 0;
     fhir:Element.extension [
       fhir:index 0;
       fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-authorprimarysource" ];
       fhir:Extension.valueBoolean [ fhir:value "true"^^xsd:boolean ]     ];
     fhir:Reference.reference [ fhir:value "PractitionerRole/VAERSAuthorRole" ]
  ];
  fhir:Composition.title [ fhir:value "ICSR Submission"];
  fhir:Composition.section [
     fhir:index 0;
     fhir:Composition.section.title [ fhir:value "Reaction/Event" ];
     fhir:Composition.section.code [
       fhir:CodeableConcept.coding [
         fhir:index 0;
         fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS" ];
         fhir:Coding.code [ fhir:value "ReactionEvent" ]       ]     ];
     fhir:Composition.section.text [
       fhir:Narrative.status [ fhir:value "generated" ];
       fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\">Developed acute facial nerve paralysis after ED administration of influenza vaccine</div>"     ];
     fhir:Composition.section.entry [
       fhir:index 0;
       fhir:Reference.reference [ fhir:value "AdverseEvent/VAERSExampleEvent" ]     ]
  ], [
     fhir:index 1;
     fhir:Composition.section.title [ fhir:value "Drug Information" ];
     fhir:Composition.section.code [
       fhir:CodeableConcept.coding [
         fhir:index 0;
         fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS" ];
         fhir:Coding.code [ fhir:value "DrugInformation" ]       ]     ];
     fhir:Composition.section.text [
       fhir:Narrative.status [ fhir:value "generated" ];
       fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\">ED administration of influenza vaccine</div>"     ];
     fhir:Composition.section.entry [
       fhir:index 0;
       fhir:Reference.reference [ fhir:value "Immunization/VAERSExampleImmunization" ]     ], [
       fhir:index 1;
       fhir:Reference.reference [ fhir:value "MedicationAdministration/VAERSHydrocortisoneAdministration" ]     ]
  ], [
     fhir:index 2;
     fhir:Composition.section.title [ fhir:value "Case Summary Narrative" ];
     fhir:Composition.section.code [
       fhir:CodeableConcept.coding [
         fhir:index 0;
         fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS" ];
         fhir:Coding.code [ fhir:value "CaseSummaryNarrative" ]       ]     ];
     fhir:Composition.section.text [
       fhir:Narrative.status [ fhir:value "generated" ];
       fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\">Header: FDA CBER BEST Automated AE Reporting Prototype Case BEST Detection Phenotype Algorithm: sharepoint link BEST Certainty: Definite BEST Severity: Non-Severe BEST Causality: Probable Onset location for reaction: Preliminary investigation results: Developed acute facial nerve paralysis after ED administration of influenza vaccine; Reaction Type: vax_bells_palsy; Illness at Time of Vaccination: 1. illness, Problem, Chronic systolic (congestive) heart failure, Date 20170430; Notes: 1. notes, Progress Note - Nurse, Patient Care Documentation, Progress Note : Patient suffered face weakness from unknown cause. Patient had idiopathic facial nerve palsy and showed rapid progression. Palsy improved lot facial paralysis identified., Date 20170423;</div>"     ]
  ], [
     fhir:index 3;
     fhir:Composition.section.title [ fhir:value "Relevant Medical History" ];
     fhir:Composition.section.code [
       fhir:CodeableConcept.coding [
         fhir:index 0;
         fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS" ];
         fhir:Coding.code [ fhir:value "RelevantMedicalHistory" ]       ]     ];
     fhir:Composition.section.text [
       fhir:Narrative.status [ fhir:value "generated" ];
       fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\">Long term (current) use of anticoagulants</div>"     ]
  ].

# - ontology header ------------------------------------------------------------

 a owl:Ontology;
  owl:imports fhir:fhir.ttl.